ACR-368 pursues accelerated approval in serous endometrial cancer on 52% cORR; the bet is whether FDA accepts Phase 2b as registrational without a Phase 3 requirement first

Acrivon is a clinical-stage company developing a targeted cancer drug for serous endometrial cancer that has not yet been approved.

ACR-368, a CHK1/2 inhibitor, is in a registrational-intent Phase 2b trial targeting platinum- and anti-PD-1-failed serous endometrial cancer patients with up to two prior lines of therapy. The thesis resolves if FDA accepts the Phase 2b data package—anchored by a 52% cORR in serous EC—as the basis for accelerated approval without mandating Phase 3 completion first. The primary risk is regulatory: FDA may require the Phase 3 confirmatory trial to mature before granting any approval, and lifileucel from Iovance addresses an overlapping post-platinum/post-checkpoint endometrial population with a competing modality.